Medtronic presents pivotal artificial pancreas data at ADA, as Insulet details its own plans

June 13, 2016 | By Stacy Lawrence

Medtronic reported pivotal data for its hybrid closed-loop system at the American Diabetes Association conference in New Orleans, LA, over the weekend. The data show that the hybrid closed-loop system helped to decrease A1c levels as well as reduce variability in sensor glucose values for 124 patients with Type 1 diabetes.

No major adverse events were reported for the study, which encompassed 12,389 patient days.

The system includes a Medtronic MiniMed 670G insulin pump, fourth-generation glucose sensors and a control algorithm. In addition to the system itself, researchers monitored blood glucose levels more than four times daily via traditional finger-stick monitoring as well as via Abbott's i-STAT handheld device. Patients also calibrated the closed-loop sensors periodically.

The three-month study found that the hybrid closed-loop system resulted in a mean reduction of A1c to 6.9% +/- 0.6% from 7.4% +/- 0.9%. This was the primary outcome measure of the study. The standard recommendation is to reduce HbA1c to <7%.

Sensor glucose levels varied only slightly from baseline level established during a 2-week lead-in period. At the end of the study, 99 of the participants opted to enter the continued-access program for the hybrid closed-loop device.

"The HCL system was safe, acceptable, and associated with improved glucose control during extended at-home use," the researchers concluded.

A separate study of 12 adults and 16 adolescents found that overnight use of the closed-loop system improved time in the target glucose range for the adults and reduced nocturnal hypoglycemia in the adolescents.

Medtronic has previously said that it will submit this month to the FDA for its hybrid closed-loop system, with an approval anticipated for next spring.

For its part, smaller competitor Insulet, also updated on its own artificial pancreas ambitions. Its artificial pancreas system incorporates its Omnipod insulin platform along with a DexCom continuous glucose monitor that's controlled by an algorithm it in-licensed from Mode AGC in February.

The system is currently in a feasibility study using the algorithm and a next-gen Omnipod prototype. Insulet expects to start on-body trials for the system later this year. It presented data on the recently in-licensed artificial pancreas algorithm at the ADA conference.